These Extensions are meant to speed up your risk assessment activities, such as identifying, evaluating and mitigating risks.
Some of them require special templates, usually provided in the extension download.
Contact the Aligned Element Support Team for advice on how to apply these extensions in the quickest possible way.
The Technical Report, IEC TR 80002-1 "Medical device software - Part 1 Guidance on the application of ISO 14971 to medical device software", takes a software angle on ISO 14971, just as the title suggests.
Annex B of the report elaborates on possible software hazards and factors to consider in order to properly assess whether and how they are applicable to a particular device.
To assist the risk identification of software hazards, use this extension, inspired by the Annex B of IEC/TR 80002-1.
You may of course expand this hazard list with hazards that are particular to your device and the conditions under which it needs to operate.
Aligned Elements users can kick start their risk identification process by downloading and importing our ISO 14971:2012 Annex C Extension, assessing them, and start generating risks and mitigation.
The ISO 14971:2012 Annex C Extension contains:
This Extension facilitates the assessment of the questions, the creation of both an automated assessment report of the Annex C questions as well as a starting point for generating new risks and mitigation.
This package contains predefined Potential Hazards, Causes, and Harms derived from the IMDRF Terminologies for Categorized Adverse Event Reporting.
The lists are applicable to Aligned Elements projects using Risk Assessments using the Preliminary Hazard Analysis method.
A great way of conducting a structured risk identification is to start off with a known list of potential hazards. ISO 14971:2012 Annex E (ISO 14971:2019 Annex E) provides such a list that can be downloaded and imported below.
The ISO 14971 Hazard Examples contains:
The imported items correspond to the Hazard Design Control in the Aligned Elements FDA Templates.
In support of the Preliminary Hazard Analysis model in Aligned Elements, here are five PHA Harms based on the example Five Qualitative Severity Levels from ISO 14971 Table D. 3.